Methods and apparatus for filtering a body lumen

ABSTRACT

An implantable lumen filter is described. The filter may include a body formed from an elongate member. The body may include loops encircling an axis extending along the length of the body. The body may be sized to be implanted into a body lumen. The body may be capable of transitioning from a collapsed state to a deployed state. The filter may include a first group of a plurality of members positioned around at least one loop of said body. At least a portion of the plurality of members may be oriented towards the axis. The plurality of members may be arranged to capture and/or lyse particulates of a selected size and/or to inhibit the particulates from passing through the body. Methods to of making, deploying, and retrieving the same are described.

CROSS-REFERENCE TO RELATED APPLICATIONS

This Patent Application is Continuation of U.S. patent application Ser.No. 13/131,254, filed on 14 Dec. 2011, which is now allowed. U.S. patentapplication Ser. No. 13/131,254 is a U.S. National Stage ofInternational Application No. PCT/US2009/068291, filed on 16 Dec. 2009,which claims the benefit of and priority to U.S. Provisional PatentApplication having Ser. No. 61/138,461, filed on 17 Dec. 2008. Thedisclosures of the foregoing are incorporated herein by reference intheir entireties.

FIELD OF THE INVENTION

The present invention relates generally to medical devices. Moreparticularly the present invention relates to methods and apparatus forfiltering a body lumen.

BACKGROUND OF THE INVENTION

Vein thrombosis is a medical condition wherein a blood clot, orthrombus, has formed inside a vein. Such a clot often develops in thecalves, legs, or lower abdomen, but can also affect other vasculature inthe body. The clot may partially or completely block bodily fluid flowand may break off and travel through the bloodstream (as an embolus).Commonly, clots are caused by a pooling of blood in the vein, often whenan individual is bed-ridden for an abnormally long duration of time, forexample, when resting following surgery or suffering from a debilitatingillness, such as a heart attack or traumatic injury. However, there areother situations that may cause the formation of a blood clot.

Vein thrombosis is a serious problem because of the danger that the clotmay break off and travel through the bloodstream to the lungs, causing apulmonary embolism. This is similar to a blockage of the blood supply tothe lungs that causes severe hypoxia and cardiac failure, whichfrequently result in death. For many patients, anti-coagulant drugtherapies may be sufficient to dissipate the clots. For example,patients may be treated with anticoagulants such as heparin and withthrombolytic agents such as streptokinase.

Unfortunately, some patients may not respond to such drug therapy or maynot tolerate such therapy. Also, there may be other reasons why ananticoagulant is not desirable. For example, patients may have an acutesensitivity to heparin or may suffer from prolonged internal and/orexternal bleeding as a result of such drug therapies. Also, such drugtherapies simply may be ineffective in preventing recurrent pulmonaryemboli. In such circumstances, surgical procedures may be necessary toreduce the likelihood of pulmonary emboli. Mechanical interruption ofthe inferior vena cava typically presents an effective method ofpreventing of pulmonary embolisms.

Vena cava filters are devices which are implanted in the inferior venacava, providing a mechanical barrier to undesirable particulates. Thefilters may be used to filter peripheral venous blood clots and/or otherparticulates, which if remaining in the blood stream can migrate in thepulmonary artery or one of its branches and cause harm. However, venacava filters may be improved.

Therefore, methods and apparatus for filtering a body lumen may beuseful.

BRIEF DESCRIPTION OF THE DRAWINGS

In order to describe the manner in which the above-recited and otheradvantages and features of the invention can be obtained, a moreparticular description of the invention briefly described above will berendered by reference to specific embodiments thereof which areillustrated in the appended drawings. Understanding that these drawingsdepict only typical embodiments of the invention and are not thereforeto be considered to be limiting of its scope, the invention will bedescribed and explained with additional specificity and detail throughthe use of the accompanying drawings.

FIG. 1 is a side view of an implantable lumen filter.

FIG. 2 is an end view of the implantable lumen filter of FIG. 1.

FIG. 3 illustrates an embodiment of an implantable lumen filter formedfrom a tube structure.

FIG. 4 illustrates an embodiment of an implantable lumen filter formedfrom a flat member.

FIGS. 5A-5B are partial cutaway views of an example of an implantablelumen filter.

FIGS. 6A-6B are partial cutaway views of another example of animplantable lumen filter.

FIGS. 7A-7B are partial cutaway views of a further example of animplantable lumen filter.

FIGS. 8A-8B are partial cutaway views of a still further example of animplantable lumen filter.

FIG. 9 is a partial cutaway view of yet another example of animplantable lumen filter.

FIG. 10 is a side isometric view of the implantable lumen filter of FIG.9.

FIGS. 11-16 are partial cutaway views of various examples of implantablelumen filters.

FIG. 17 illustrates an exemplary subject for an implantable lumenfilter.

FIGS. 18-19 illustrate exemplary embodiments of retrieving mechanismsfor implantable lumen filters.

FIGS. 20-21 are partial cutaway views of various examples of implantablelumen filters.

FIG. 22 illustrates another example of retrieving mechanism forimplantable lumen filters.

FIGS. 23-24 are side views of various examples of implantable lumenfilters.

FIGS. 25A-25G′ illustrate various steps in the deployment and retrievalof an example implantable lumen filter.

It should be noted that the figures are not drawn to scale and thatelements of similar structures or functions are generally represented bylike reference numerals for illustrative purposes throughout thefigures. It also should be noted that the figures are only intended tofacilitate the description of embodiments of the present invention.

DETAILED DESCRIPTION

The configurations described herein extend generally to implantablelumen filters, retrieving mechanisms, methods of manufacturing the same,and methods for filtering a body lumen. By way of example only, a bodylumen may include a blood vessel. Filtering of the body lumen may beperformed by implantable lumen filters. For instance, configurations ofimplantable lumen filters (e.g. including vena cava and/or other lumenfilters), are described. Components of implantable filters also aredescribed.

Some implantable lumen filters may be designed to capture, inhibit,and/or lyse particulates of a particular size within the lumen. Manyimplantable lumen filters may be generally tapered from a distal endtoward a proximal end. For example, implantable lumen filters may begenerally cone shaped. As a result of their shape, many implantablelumen filters may direct particulates towards and capture, inhibit,and/or lyse the particulates within a central portion of the lumen. Asparticulates collect within the filter near the center of the lumen,flow within the lumen, such as bodily fluid flow, is disrupted and/orreduced. This can lead to an occlusion thereby reducing the usablelifespan of the filter and potentially causing harm to a patient.

Example implantable lumen filters described herein may be configured todirect particulates within a lumen radially outwardly and/or to collectparticulates proximate an inner wall of the lumen. By so doing, someexample implantable lumen filters described herein can reduce oreliminate obstructions within the central portion of the lumen. Someimplantable lumen filters may provide enhanced durability. As a result,these implantable lumen filters may have longer usable lifespans and/orenhanced safety characteristics.

Some embodiments of implantable lumen filters described herein may havea generally spiral or helical shape. Implantable lumen filters may beused in various vasculatures. For example, embodiments of implantablelumen filters may be configured for use in the vena cava.

During retrieval, a second filter can be temporarily deployed above thefilter that to is being retrieved to prevent breakage of earliercaptured particulates, such as emboli. Multiple filters may be usedalong a length of a body lumen during retrieval or otherwise. The use ofmultiple filters may reduce the likelihood that a particulate may harm apatient. For example, when one filter fills, others may be positioneddownstream to capture, inhibit, and/or lyse additional particulates.

The spiral filters can be deployed and recovered from a body lumen, suchas the vena cava through various access sites. For example, a spiralfilter may be deployed and/or removed through a femoral approach, abrachial approach, or other access sites.

The example implantable lumen filters described herein may bemanufactured from any suitable material. For example, an implantablelumen filter may be made from a biocompatible shaped memory material(SMM). For example, the SMM can be shaped in a manner that allows for apre-deployed configuration while within a delivery device, but canautomatically retain the memory shape of the filter once deployed fromthe delivery device and into the body lumen. SMMs have a shape memoryeffect in which they can be made to remember a particular shape. Once ashape has been remembered, the SMM may be bent out of shape or deformedand then returned to its original shape by unloading from strain orheating. Typically, SMMs can be shape memory alloys (SMA) comprised ofmetal alloys, or shape memory plastics (SMP) comprised of polymers. Thematerials can also be referred to as being superelastic.

Usually, an SMA can have an initial shape that can then be configuredinto a memory shape by heating the SMA and conforming the SMA into thedesired memory shape. After the SMA is cooled, the desired memory shapecan be retained. This allows for the SMA to be bent, straightened,twisted, compacted, and placed into various contortions by theapplication of requisite forces; however, after the forces are released,the SMA can be capable of returning to the memory shape. The main typesof SMAs are as follows: copper-zinc-aluminium; copper-aluminium-nickel;nickel-titanium (NiTi) alloys known as nitinol; nickel-titaniumplatinum; nickel-titanium palladium; and cobalt-chromium-nickel alloysor cobalt-chromium-nickel-molybdenum alloys known as elgiloy alloys. Thetemperatures at which the SMA changes its crystallographic structure arecharacteristic of the alloy, and can be tuned by varying the elementalratios or by the conditions of manufacture. This can be used to tune thefilter so that it reverts to the memory shape within the body lumen whendeployed at body temperature and when being released from the deliverydevice.

For instance, the primary material of a filter can be of a NiTi alloythat forms to superelastic nitinol. In the present case, nitinolmaterials can be trained to remember a certain shape, retained withinthe delivery device, and then deployed from the delivery device so thatthe filter expands within the body lumen. Also, additional materials canbe added to the nitinol depending on the desired characteristic. Thealloy may be utilized having linear elastic properties or non-linearelastic properties.

An SMP is a shape-shifting plastic that can be fashioned into a filterin accordance with the present disclosure. Also, it can be beneficial toinclude at least one layer of an SMA and at least one layer of an SMP toform a multilayered body; however, any appropriate combination ofmaterials can be used to form a filter. When an SMP encounters atemperature above the lowest melting point of the individual polymers,the blend makes a transition to a rubbery state. The elastic modulus canchange more than two orders of magnitude across the transitiontemperature (Ttr). As such, an SMP can formed into a desired shape of afilter by heating it above the Ttr, fixing the SMP into the new shape,and cooling the material below Ttr. The SMP can then be arranged into atemporary shape by force and then resume the memory shape once the forcehas been applied. Examples of SMPs include, but are not limited to,biodegradable polymers, such as oligo(ε-caprolactone)diol,oligo(ρ-dioxanone)diol, and non-biodegradable polymers such as,polynorborene, polyisoprene, styrene butadiene, polyurethane-basedmaterials, vinyl acetate-polyester-based compounds, and others yet to bedetermined. As such, any SMP can be used in accordance with the presentdisclosure.

A filter body having at least one layer made of an SMM or suitablesuperelastic material, and other suitable layers can be compressed orrestrained in its delivery configuration within the delivery device, andthen deployed into the body lumen so that it transforms to the trainedshape. Thus, providing an implantable lumen filter that may transitionfrom a compressed state toward a deployed shape.

Also, the filter can be comprised of a variety of known suitabledeformable materials, including stainless steel, silver, platinum,tantalum, palladium, nickel, titanium, nitinol, nitinol having tertiarymaterials, niobium-tantalum alloy optionally doped with a tertiarymaterial cobalt-chromium alloys, or other biocompatible materials. Suchbiocompatible materials can include a suitable biocompatible polymer inaddition to or in place of a suitable metal. The polymeric clip caninclude biodegradable or bioabsorbable materials, which can be eitherplastically deformable or capable of being set in the deployedconfiguration.

In one embodiment, the filter may be made from a superelastic alloy suchas nickel-titanium or nitinol, and includes a ternary element selectedfrom the group of chemical elements such as iridium, platinum, gold,rhenium, tungsten, palladium, rhodium, tantalum, silver, ruthenium,hafnium, other radiopaque materials, alloys thereof, or combinationsthereof. The added ternary element may improve the radiopacity of thenitinol filter. The nitinol filter may have improved radiopacity yetretain its superelastic and shape memory behavior and further maymaintain a thin body thickness for high flexibility. For instance, thefilter according to the present disclosure may have 42.8 atomic percentnickel, 49.7 atomic percent titanium, and 7.5 atomic percent platinum.

These materials may include at least one beneficial agent incorporatedinto the material and/or coated over at least a portion of the material.The beneficial agents may be applied to implantable lumen filters thathave been coated with a polymeric compound. Incorporation of thecompound or drug into the polymeric coating of the implantable lumenfilter can be carried out by dipping the polymer-coated implantablelumen filter into a solution containing the compound or drug for asufficient period of time (such as, for example, five minutes) and thendrying the coated implantable lumen filter, such as by way of air dryingfor a sufficient period of time (such as, for example, 30 minutes). Thepolymer-coated implantable lumen filter containing the beneficial agentmay then be delivered to a body vessel.

The pharmacologic agents that can be effective in preventing restenosiscan be classified into the categories of anti-proliferative agents,anti-platelet agents, anti-inflammatory agents, anti-thrombotic agents,and thrombolytic agents. Anti-proliferative agents may include, forexample, crystalline rapamycin. These classes can be furthersub-divided. For example, anti-proliferative agents can be anti-mitotic.Anti-mitotic agents inhibit or affect cell division, whereby processesnormally involved in cell division do not take place. One sub-class ofanti-mitotic agents includes vinca alkaloids. Representative examples ofvinca alkaloids include, but are not limited to, vincristine,paclitaxel, etoposide, nocodazole, indirubin, and anthracyclinederivatives, such as, for example, daunorubicin, daunomycin, andplicamycin. Other sub-classes of anti-mitotic agents includeanti-mitotic alkylating agents, such as, for example, tauromustine,bofumustine, and fotemustine, and anti-mitotic metabolites, such as, forexample, methotrexate, fluorouracil, 5-bromodeoxyuridine, 6-azacytidine,and cytarabine. Anti-mitotic alkylating agents affect cell division bycovalently modifying DNA, RNA, or proteins, thereby inhibiting DNAreplication, RNA transcription, RNA translation, protein synthesis, orcombinations of the foregoing.

Anti-platelet agents are therapeutic entities that act by (1) inhibitingadhesion of platelets to a surface, typically a thrombogenic surface,(2) inhibiting aggregation of platelets, (3) inhibiting activation ofplatelets, or (4) combinations of the foregoing. Activation of plateletsis a process whereby platelets are converted from a quiescent, restingstate to one in which platelets undergo a number of morphologic changesinduced by contact with a thrombogenic surface. These changes includechanges in the shape of the platelets, accompanied by the formation ofpseudopods, binding to membrane receptors, and secretion of smallmolecules and proteins, such as, for example, ADP and platelet factor 4.Anti-platelet agents that act as inhibitors of adhesion of plateletsinclude, but are not limited to, eptifibatide, tirofiban, RGD(Arg-Gly-Asp)-based peptides that inhibit binding to gpIIbIIIa or αvβ3,antibodies that block binding to gpIIaIIIb or αvβ3, anti-P-selectinantibodies, anti-E-selectin antibodies, compounds that block P-selectinor E-selectin binding to their respective ligands, saratin, and anti-vonWillebrand factor antibodies. Agents that inhibit ADP-mediated plateletaggregation include, but are not limited to, disagregin and cilostazol.

Anti-inflammatory agents can also be used. Examples of these include,but are not limited to, prednisone, dexamethasone, hydrocortisone,estradiol, fluticasone, clobetasol, and non-steroidalanti-inflammatories, such as, for example, acetaminophen, ibuprofen,naproxen, and sulindac. Other examples of these agents include thosethat inhibit binding of cytokines or chemokines to the cognate receptorsto inhibit pro-inflammatory signals transduced by the cytokines or thechemokines. Representative examples of these agents include, but are notlimited to, anti-IL1, anti-IL2, anti-IL3, anti-IL4, anti-IL8, anti-IL15,anti-IL18, anti-GM-CSF, and anti-TNF antibodies.

Anti-thrombotic agents include chemical and biological entities that canintervene at any stage in the coagulation pathway. Examples of specificentities include, but are not limited to, small molecules that inhibitthe activity of factor Xa. In addition, heparinoid-type agents that caninhibit both FXa and thrombin, either directly or indirectly, such as,for example, heparin, heparin sulfate, low molecular weight heparins,such as, for example, the compound having the trademark Clivarin®, andsynthetic oligosaccharides, such as, for example, the compound havingthe trademark Arixtra®. Also included are direct thrombin inhibitors,such as, for example, melagatran, ximelagatran, argatroban, inogatran,and peptidomimetics of binding site of the Phe-Pro-Arg fibrinogensubstrate to for thrombin. Another class of anti-thrombotic agents thatcan be delivered is factor VII/VIIa inhibitors, such as, for example,anti-factor VII/VIIa antibodies, rNAPc2, and tissue factor pathwayinhibitor (TFPI).

Thrombolytic agents, which may be defined as agents that help degradethrombi (clots), can also be used as adjunctive agents, because theaction of lysing a clot helps to disperse platelets trapped within thefibrin matrix of a thrombus. Representative examples of thrombolyticagents include, but are not limited to, urokinase or recombinanturokinase, pro-urokinase or recombinant pro-urokinase, tissueplasminogen activator or its recombinant form, and streptokinase.

One or more immunosuppressant agents may be used Immunosuppressantagents may include, but are not limited to, IMURAN® azathioprine sodium,brequinar sodium, SPANIDIN® gusperimus trihydrochloride (also known asdeoxyspergualin), mizoribine (also known as bredinin), CELLCEPT®mycophenolate mofetil, NEORAL® Cylosporin A (also marketed as differentformulation of Cyclosporin A under the trademark SANDIMMUNE®), PROGRAF®tacrolimus (also known as FK-506), sirolimus and RAPAMUNE®, leflunomide(also known as HWA-486), glucocorticoids, such as prednisolone and itsderivatives, antibody therapies such as orthoclone (OKT3) and Zenapax®,and antithymyocyte globulins, such as thymoglobulins. In addition, acrystalline rapamycin analog, A-94507, SDZ RAD (a.k.a. Everolimus),and/or other immunosuppressants.

Referring now to the figures, FIG. 1 illustrates an example of animplantable lumen filter 100. The filter 100 may incorporate any of thefeatures and/or components of any of the filters described herein. Insome embodiments, the filter 100 can be formed into a spiral, helical,other winding shape, or combinations thereof. For instance, a wire,ribbon, plate, other shape, or combinations thereof may be coiled (i.e.wound) to from a body 111 and/or other filter components in a desiredconfiguration, such as the helical configuration shown in FIG. 1. Inanother example, the body 111 and/or other components of the filter 100can be formed from a tube that is formed in a desired configurationusing forming techniques such as using laser cutting, photolithography,chemical etching, EDM, milling, hydro-cutting, other forming techniques,or combinations thereof.

The body 111 may include loops (i.e. windings) that may be orientedabout an axis 101 extending along the length of the body. As shown inFIG. 1, the axis 101 may be generally straight. In other embodiments,the axis 101 may vary along the length of to the filter 100. Forexample, the axis 101 may be curved or otherwise shaped. The lengthgenerally is defined as the length from end to end of the helical shapethat forms the body of the filter; the width being defined as the cutbreadth that forms each loop of the spiral configuration; and thethickness being defined as the depth of the material used to form thefilter. The loops of the body 111 may be spaced apart from each other,as shown in FIG. 1. The spacing may vary or be the same from loop toloop.

The body 111 is sized to be implanted into a body lumen. The outerdiameter of the body 111 is dimensioned to fit within a body lumendepending on the size of the lumen. The diameter, for example, can bebetween about 0.5 mm to about 70 mm. The length of the filter can besized to meet various requirements, such as filtration, spacing, otherrequirements, or combinations of the same. For example, the length canbe sized between about 25 mm and 50 mm. The thickness of the materialmay be based on the material selection and properties and can be sized,for example, between 0.006 cm and about 0.009 cm. Other sizes may beselected based on the diameter needed to fit inside the body lumen, theamount of filtration needed, the size of the material used to form thefilter, other considerations, or combinations thereof.

Impeding members 112 (referred to generally as 112 and individually as121, 122, 123, 124, 131, 132, 133, 134, 135, 136, 141, 142, 143, 144)may be formed as part of or attached to the filter body 111 and mayinclude a first end 112 a and/or a second end 112 b. The impedingmembers 112 may facilitate the direction of particulates away from thecenter of the filter 100, which can potentially obstruct bodily fluidflow. In embodiments where the impeding members 112 are attached to thefilter 100, the first end 112 a can be attached to the body 111 bywelding, soldering, adhering, other attaching methods, or combinationsthereof. Alternatively and/or in addition, the first end 112 a may beintegrally formed with the body 111. The impeding members 112 may extendfrom the first end 112 a toward the second end 112 b.

The members 112 can be oriented with respect to the flow of bodily fluidthrough the body lumen. In the embodiment shown in FIG. 1, some members112 (121, 122, 123, 124) are shown oriented at an angle A from the axis101. Angle A can be arranged between about 10 degrees and about 80degrees from the central axis 101 of the filter body 111 near theimpeding member 112. The impeding member 112 may be generally orientedtoward the bodily fluid flow so particulates traveling in the flow maybe contacted by the second end 112 b of the impeding member 112.

The filter 100 can include one or more members 112 distributed aroundthe filter body 111. The members 112 can be arranged at any point aroundthe body 111. The members 112 can be evenly and/or unevenly distributedaround the body 111. For instance, the members 112 may be positioned atregular intervals, such as for example every ninety degrees about thebody 111. In another example, the members 112 may be positioned atirregular intervals (i.e. at least two members being separated byfifteen degrees and at least two other members being separated by fortyfive degrees).

The impeding members 112 may be arranged in groups. The groups ofmembers 112 can be arranged around a loop of the body 111 and can beconfigured to extend at least a portion of the member 112 towards anaxis 101 running along the length of the body. The members 112 may bearranged to capture, inhibit, and/or lyse particulates and bedimensioned to allow blood components smaller than the selected size topass between the members. In the present embodiment, the filter 100 mayinclude three groups 120, 130, 140. In other embodiments more or fewergroups may be used.

The groups 120, 130, 140 may have various configurations. The groups120, 130, 140 may include at least one member 112. The members 112 ineach group 120, 130, 140 may vary in size, length, orientation,material, other characteristics, or combinations thereof from themembers 112 in the group 120, 130, 140 and/or the members 112 in othergroups 120, 130, 140. The groups 120, 130, 140 may have the same numberof members 112, different numbers of members 112, or combinationsthereof. For example, the first group 120 may include four members 121,122, 123, 124, the second group 130 may include six members 131, 132,133, 134, 135, 136, and the third group 140 may include four members141, 142, 143, 144.

In the present embodiment, the first group 120 may include four members121, 122, 123, 124 that may be placed around a loop of the body 111 nearone end of the filter 100. The four members 121, 122, 123, 124 can bespaced around the body 111 at about 90 degree spacing radiating towardsthe central axis 101 of the filter 111 in a generally circular fashion.The first group 120 is angled against the bodily fluid flow through thebody lumen as discussed above. The first group 120 can be angled at asteep incline to direct the particulates away from the central axis 101and towards the body 111 of the filter 100. The steep angle, forexample, may range between about 10 degrees and about 45 degrees fromthe central axis 101 of the filter 100. For instance the angle can beset at about 30 degrees.

A second group 130 may include six members 131, 132, 133, 134, 135, 136.The second group 130 can be offset a distance B from the first group120. The distance B may be a longitudinal distance. The distance B, forexample, can be about ⅔ of the total length of the body 111. The secondgroup 130 may be placed around a loop of the body 111 and spaced about60 degrees apart from each other radiating generally towards the centralaxis 101 of the filter 100. The second group 130, in the presentembodiment, may contain more members 131, 132, 133, 134, 135, 136 thanthe first group 120. In other embodiments, the second group 130 maycontain the same number of or fewer members 112 than the first group120. The members 131, 132, 133, 134, 135, 136 may be arranged tocapture, inhibit, and/or lyse particulates in the body lumen. The secondgroup 130, in the present embodiment, may be configured to have a moregradual angle, such as an angle between about 45 degrees and about 85degrees from the central axis 101 of the filter 100. A more gradualangle may facilitate capturing, inhibiting, and/or lysing theparticulates. For instance the angle can be set at about 60 degrees.

In the present embodiment, the third group 140 may include four members141, 142, 143, 144. In other embodiments, the third group 140 maycontain the same number of or fewer members 112 than the first and/orsecond group 120, 130. The third group 140 may be placed around a loopof the body 111 near an end of the filter 100 opposite the first group120. The four members 141, 142, 143, 144 can be spaced around the body111 at about 90 degree spacing radiating towards the central axis 101 ofthe filter 100 in a circular fashion. The third group 140 may be angledagainst the bodily fluid flow through the body lumen as discussed above.The third group 140 may be angled at a gradual incline to furthercapture, inhibit, and/or lyse particulates in the filter 100. Thegradual angle, for example, may range between about 45 degrees and about85 degrees from the central axis 101 of the filter 100. For instance theangle can be set at about 45 degrees.

The impeding members 112 may be angled to facilitate the direction ofparticulates away from the central axis 101 to prevent obstruction ofthe bodily fluid flow. Members 112 that are non-perpendicular to thecentral axis 101 may capture, inhibit, and/or lyse particulates near thecentral axis 101 of the filter 100 and may move particulates toward thebody 111 and away from the central axis 101.

FIG. 2 is an end view of the implantable lumen filter 100 illustrated inFIG. 1. The impeding members 112 may be staggered to capture, inhibit,and/or lyse particulates that may be present in a bodily fluid flowthrough a body lumen. The members 112 in the first group 120 may bearranged with about 90 degree spacing and/or may extend toward to thecentral axis 101 of the filter 100. The members 112 of the second group130 may be arranged with about 60 degree spacing and/or extending overhalf the distance toward the central axis 101 of the filter 100. Themembers 112 of the third group 140 may be arranged with about 90 degreespacing and/or extending about the total distance toward the centralaxis 101 of the filter 100, such as ⅚ of the total distance. The thirdgroup 140 can be offset from the first group 120 by about 45 degrees tostagger the members 112 through the filter 100. As discussed above, themembers 112 of the various groups 120, 130, 140 may vary in size,length, orientation, material, other characteristics, or combinationsthereof from the members 112 in the group 120, 130, 140 and/or themembers 112 in other groups 120, 130, 140.

Although the implantable lumen filter 100 illustrated in FIGS. 1 and 2is an example of one embodiment, other configurations can beimplemented. For example, the groups 120, 130, 140 can include more orless members 112, the members 112 can have varying positioning, such asangles or tilts, and can be arranged around the filter 100 with varyingspacing, and the filter 100 can include more or less groups 120, 130,140 than illustrated, other variations, or combinations thereof. Afilter material can also be attached to and/or span across the impedingmembers 112 to add a further layer of filtration to capture, inhibit,and/or lyse finer particulates. The material may include a urethane,rubber, other material, or combinations thereof and/or holes formed bylaser cutting, perforation, other forming techniques, or combinationsthereof, which may be adhered to the impeding members 112 to form afiltration wall within the filter body 111. Various beneficial agentsmay be applied to the filter material or the body 111 of the filter 100to facilitate lysing of particulates and/or to facilitate a reduction inbody lumen growth around the filter 100 while in place for long periodsof time.

A plurality of protruding engaging portions may be formed with orattached to the filter. If the engaging portions are attached to thefilter, they can be attached by welding, adhering, or other techniquesto affix a component to the body 111. The engaging portions may beconfigured to hold the filter 100 in place in a body lumen. The engagingportions can be strategically placed around the body 111 to increase thestability of the filter 100. The engaging portions may engage an innersurface of a body lumen. The engaging portions can include a tissuepiercing portion that is configured to pierce a portion of the innersurface of the body lumen and/or a tissue engaging portion that isconfigured to engage but not pierce the inner surface of the body lumen.

FIGS. 3 and 4 illustrate various embodiments of implantable lumenfilters manufactured from a tube and a flat member. These manufacturingtechniques may be used with any of the filters described herein. Forinstance, the filter 100 shown in FIGS. 1 and 2 may be manufacturedusing these techniques.

The filter shown in FIG. 3 can be formed from a tube 150 that is cutinto a spiral, helical, or other shape using the forming techniquesdescribed herein. The tube 150 shown in FIG. 3 is formed using lasercutting. The body of the filter can be formed in a continuous line 152around the tube 150. Forming the body using laser cutting may include asingle continuous cut, multiple intersecting cuts, other cuts, orcombinations thereof. Additional forming may be performed to formsections 156 into impeding members (discussed in further detail below).For instance, material may be removed along a line 154 from thecontinuous line 152. The sections 156 may then be bent towards a centralaxis of the tube 150.

In another example, the filter can be manufactured from a strip 160 ofmaterial (as shown in FIG. 4) that may be rolled into a spiral, helical,or other shape. The strip 160 may be formed to include sections 164 thatmay be formed into impeding members. For instance, material may beremoved from the strip 160 along a line 162. The sections 164 can bebent toward the desired position by forming and/or heat treating thematerial.

In another example, the filter body can be formed by rolling a wire to aflattened cross section (similar to the configuration shown in FIG. 4)and forming the impeding members from the flattened wire (as discussedbelow). The wire can also be round and rolled into a spiral, helical, orother shape. In other examples, the impeding members can be connected tothe filter body by mechanical bonding, adhesives, thermal bonding,chemical bonding, combinations thereof, or other manufacturingtechniques usable to mount, couple, or attach two medical components.The filter and its components can be formed from any of the materialsdescribed above.

FIGS. 5A and 5B illustrate an example of an implantable lumen filter170. The filter 170 is shown in a partial cutaway flat state in FIG. 5Aand a partial cutaway coiled state in FIG. 5B. The filter 170 mayincorporate any of the features and/or components of any of the filtersdescribed herein.

The filter 170, in this example, may include a body 171 that coils (i.e.winds) in a spiral, helical, or other configuration. The body 171 mayinclude impeding members 172, 173 having a first ends 172 a, 173 a andsecond ends 172 b, 173 b. The impeding members to 172, 173 may beconfigured to extend from their first ends 172 a, 173 a towards thecenter (i.e. a central axis) of the filter 170. The impeding members172, 173 may be bent towards the center of the filter 170 on one side ofthe body 171. The impeding members 172, 173 may be bent or otherwiseoriented toward the center of the filter 170.

The impeding members 172, 173 are shown on the same side (i.e. the rightside in FIG. 5A) of the body 171. In other embodiments, the impedingmembers 172, 173 may be positioned on the same side or differing sidesand/or on the right or the left side of the body 171 as shown in FIG.5A. A keyway 174 may be placed between the junction of the impedingmember 173 and the body 171 to reduce stress near the joint.

Engaging portions 176, 177, 178 are shown connected to a different side(i.e. the left side as shown in FIG. 5A) of the body 171 than theimpeding members 172, 173 (i.e. the right side as shown in FIG. 5A). Inother embodiments, the impeding members 172, 173 and the engagingportions 176, 177, 178 may be positioned on the same side or differingsides and/or on the right or the left side of the body 171 as shown inFIG. 5A. The engaging portions 176, 177, 178 may extend from the body171 away from the impeding members 172, 173. The impeding members 172,173 and/or the engaging portions 176, 177, 178 may be bent into theseorientations. The engaging portions 176, 177, 178 may be configured toengage and/or pierce tissue.

The engaging portions 176, 177, 178 may be arranged to engage an innersurface of a body lumen. The engaging portions 176, 177, 178, in thepresent embodiment, may be configured to pierce an inner surface of thebody lumen. In other embodiments, the filter 170 may be configured toprovide sufficient radial force to engage (without piercing) the innersurface of the body lumen. The filter 170 may be formed according to anyof the manufacturing techniques described herein.

FIGS. 6A and 6B illustrate another example of an implantable lumenfilter 180. These figures show the filter 180 in a partial cutaway flatstate in FIG. 6A and a partial cutaway coiled state in FIG. 6B. Thefilter 180 may incorporate any of the features and/or components of anyof the filters described herein.

The filter 180, in this example, may include a body 181 that coils (i.e.winds) in a spiral, helical, or other configuration. The body 181 mayinclude impeding members 182, 183 having first ends 182 a, 183 a andsecond ends 182 b, 183 b. The impeding members 182, 183 may beconfigured to extend from their first ends 182 a, 183 a towards thecenter (i.e. a central axis) of the filter 180 on one side of the body181. The impeding members to 182, 183 may be bent or otherwise orientedtoward the center of the filter 180.

The impeding members 182, 183 are shown on the different sides (i.e. theright and left side in FIG. 6A) of the body 181. In other embodiments,the impeding members 182, 183 may be positioned on the same side ordiffering sides and/or on the right or the left side of the body 181 asshown in FIG. 6A. Texturing 184, such as ridges or other surfacetexturing, may be placed on the impeding member 183 to assist incapturing, impeding, and/or lysing particulates in the bodily fluidstream.

Engaging portions 186, 187, 188 are shown connected to the same side(i.e. the right side as shown in FIG. 6A) of the body 181 as theimpeding members 182, 183. In other embodiments, the impeding members182, 183 and the engaging portions 186, 187, 188 may be positioned onthe same side or differing sides and/or on the right or the left side ofthe body 181 as shown in FIG. 6A. The engaging portions 186, 187, 188may be bent to extend out from the body 181 in a direction opposite tothe impeding members 182, 183. The engaging portions 186, 187, 188 maybe arranged to secure the filter 180 in a body lumen. The impedingmembers 182, 183 and/or the engaging portions 186, 187, 188 may be bentinto these orientations.

FIGS. 7A and 7B illustrate a further example of an implantable lumenfilter 190. These figures show the filter 190 in a partial cutaway flatstate in FIG. 7A and a partial cutaway coiled state in FIG. 7B. Thefilter 190 may incorporate any of the features and/or components of anyof the filters described herein.

The filter 190, in this example, includes a body 191 that coils (i.e.winds) in a spiral, helical, or other configuration. The body 191 mayinclude at least one impeding member 192 having a first end 192 a, asecond end 192 b, and an intermediate portion 192 c. The first end 192 aof the impeding member 192 may be connected to a portion of the body 191and may extend to the second end 192 b. The second end 192 b may beconnected to another portion of the body 191. The intermediate portion192 c of the impeding member 192 may be oriented toward the center (i.e.central axis) of the filter 190.

The impeding member 192 may be formed by cutting an aperture 194 intothe body 191. The impeding member 192 may be bent near the junctionwhere the aperture 194 meets the body 191 to extend a portion of theimpeding member 192 towards the center of the filter 190 on one side ofthe body 191. The impeding members 192, in the present embodiment, maybe integrally formed with the body 191. In other embodiments, theimpeding members 192 may be attached to the body 191 near the first end192 a by welding, soldering, adhering, other attaching methods, orcombinations thereof.

Engaging portions 196, 198 are shown connected to the same side (i.e.the right side as shown in FIG. 7A) of the body 191 as the impedingmember 192. In other embodiments, the impeding member 192 and theengaging portions 196, 198 may be positioned on the same side ordiffering sides and/or on the right or the left side of the body 191 asshown in FIG. 7A. The engaging portions 196, 198 may be bent to extendout from the body 191 in a direction opposite to the impeding member192. The engaging portions 196, 198 are arranged to secure the filter190 in a body lumen.

FIGS. 8A and 8B illustrate a still further example of an implantablelumen filter 200. These figures show the filter 200 in a partial cutawayflat state in FIG. 8A and a partial cutaway coiled state in FIG. 8B. Thefilter 200 may incorporate any of the features and/or components of anyof the filters described herein.

The filter 200, in this example, may include a body 201 that coils (i.e.winds) in a spiral, helical, or other configuration. The body 201 mayinclude impeding members 204, 205 having first ends 204 a, 205 a, secondends 204 b, 205 b, and intermediate portions 204 c, 205 c. The firstends 204 a, 205 a of the impeding members 204, 205 may be connected to aportion of the body 201 and may extend to the second ends 204 b, 205 b.The second ends 204 b, 205 b may be connected to another portion of thebody 201. The intermediate portions 204 c, 205 c of the impeding members204, 205 may be oriented toward the center (i.e. central axis) of thefilter 200.

The impeding members 204, 205 may be formed by cutting apertures 206,207 into the body 201. The apertures 206, 207 may extend from the firstends 204 a, 205 a toward the second ends 204 b, 205 b of the impedingmembers 204, 205. The impeding members 204, 205 may be bent at thejunction where the apertures 206, 207 meet the body 201 and along theimpeding members 204, 205 to extend the impeding members 204, 205towards the center of the filter 200 on one side of the body 201.Keyways 208, 209 may be placed between the junction of the impedingmember 204 and the body 201 to reduce stress at the bend.

FIGS. 9 and 10 illustrate yet another example of an implantable lumenfilter 250. These figures show a filter 250 made of wire. The filter 250may incorporate any of the features and/or components of any of thefilters described herein.

The filter 250, in this example, includes a body 251 that coils (i.e.winds) in a spiral, helical, or other configuration. The body 251 mayinclude impeding members 254, 255, 256, 257, 258 that may be formed bybending the body 251 towards the center (i.e. to central axis) of thefilter 250 at certain locations. As shown in FIG. 9, the impedingmembers 255, 256 may include first ends 255 a, 256 a, second ends 255 b,256 b, and intermediate portions 255 c, 256 c. The impeding members 254,255, 256, 257, 258 can be offset from each other to capture, inhibit,and/or lyse particulates at different sides of the filter 250. Forinstance, the impeding members 254, 255, 256, 257, 258 may becircumferentially offset about the center of the filter 250.

The filter 250 can include at least one retrieval portion 260, 262 nearat least one end of the filter 250 to facilitate retrieval of the filter250 from a body lumen by, for example, a retrieval mechanism (notshown). The retrieval portions 260, 262 may be formed by bending a looparound the ends of the wire structure of the body 251. Other retrievalmechanisms may be used.

FIG. 11 illustrates a partial cutaway view of a implantable lumen filter270 with a connected impeding member 272. The filter 270 may incorporateany of the features and/or components of any of the filters describedherein.

The impeding member 272 may include a first end 272 a and a second end272 b. The impeding member 272 may be welded to a body 271 of the filter270 near the first end 272 a. The body 271 may be coiled (i.e. wound) ina spiral, helical, or other configuration without any impeding members272 initially formed in the body 271. The impeding members 272 may beattached to the body 271 by welding, soldering, adhering, otherattaching methods, or combinations thereof. For example, the impedingmember 272 may be welded to the body 271 with a weld 274. The impedingmembers 272 may be arranged to extend towards the center (i.e. centralaxis) of the filter 270. In the present example, the narrowest portionof the impeding member 272 may be generally vertically aligned with thenarrowest portion of the body 271. In other embodiments, the impedingmember 272 and/or the body 271 may be otherwise oriented.

FIG. 12 illustrates a partial cutaway view of an implantable lumenfilter 280 with a connected impeding member 282 made from wire. Thefilter 280 may incorporate any of the features and/or components of anyof the filters described herein.

The impeding member 282 may include a first end 282 a and a second end282 b. The body 281 may be coiled (i.e. wound) in a spiral, helical, orother configuration without any impeding member 282 initially formed inthe body 281. The impeding member 282 may be attached to the body 281near the first end 282 a by welding, soldering, adhering, otherattaching methods, or combinations thereof. For example, the impedingmember 282 may be welded to the body 281 with a weld 284. The impedingto member 282 may be oriented to extend towards the center (i.e. centralaxis) of the filter 280.

FIG. 13 illustrates an implantable lumen filter 290 with a taperedimpeding member 292 shown in a partial cutaway flat state. The filter290 may incorporate any of the features and/or components of any of thefilters described herein.

The filter 290 may include a body 291 that may be coiled (i.e. wound) ina spiral, helical, or other configuration. The impeding member 292 mayinclude a first end 292 a and a second end 292 b. The impeding member292, in the present embodiment, may be integrally formed with the body291. In other embodiments, the impeding members 292 may be attached tothe body 291 near the first end 292 a by welding, soldering, adhering,other attaching methods, or combinations thereof. The impeding member292 may be bent towards the center (i.e. central axis) of the filter290. The impeding member 292 may taper to a point near the second end292 b.

The impeding member 292 may include an extension 296 near the first end292 a. The extension 296 may provide a distance from the body 291 toangle the impeding member 292 towards the filter 290. The impedingmember 292 can be configured to have an angle selected from a variety ofangles to vary the distance and/or angle from the filter 290. Theextension 296 can be arranged to extend the impeding member 292 out fromthe filter 290. The taper can be attached to the extension 296 andarranged to angle from the extension 296 towards the filter 290.

FIG. 14 illustrates an implantable lumen filter 300 with a taperedimpeding member 302 shown in a partial cutaway flat state. The filter300 may incorporate any of the features and/or components of any of thefilters described herein.

The filter 300 may include a body 301 that may be coiled (i.e. wound) ina spiral, helical, or other configuration. The impeding member 302 mayinclude a first end 302 a and a second end 302 b. The impeding member302, in the present embodiment, may be integrally formed with the body301. In other embodiments, the impeding member 302 may be attached tothe body 301 near the first end 302 a by welding, soldering, adhering,other attaching methods, or combinations thereof. The impeding member302 may be bent towards the center (i.e. central axis) of the filter300. The impeding member 302 may taper to a point near the second end302 b and may extend out from the filter 300.

FIG. 15 illustrates an implantable lumen filter 310 with a taperedimpeding member 312 shown in a partial cutaway flat state. The filter310 may incorporate any of the features and/or components of any of thefilters described herein.

The filter 310 may include a body 311 that may be coiled (i.e. wound) ina spiral, helical, or other configuration. The impeding member 312 mayinclude a first end 312 a and a second end 312 b. The impeding member312, in the present embodiment, may be integrally formed with the body311. In other embodiments, the impeding member 312 may be attached tothe body 311 near the first end 312 a by welding, soldering, adhering,other attaching methods, or combinations thereof. The impeding member312 may be bent towards the center (i.e. central axis) of the filter310. The impeding member 312 may extend out from the body 311. Theimpeding member 312 may include an annular portion 314 near the secondend 312 b. The annular portion 314 can also include an aperture 316 toallow blood to flow through the aperture 316 and/or help capture,inhibit, and/or lyse particulates in the body lumen.

FIG. 16 illustrates a further example of an implantable lumen filter320. The filter 320 may incorporate any of the features and/orcomponents of any of the filters described herein.

The filter 320 may include a body 321 that may be coiled (i.e. wound) ina spiral, helical, or other configuration. The body 321 may include animpeding member 322 that may include a first end 322 a, a second end 322b, and an intermediate portion 322 c. The first end 322 a of theimpeding member 322 may be connected to a portion of the body 321 andmay extend to the second end 322 b. The second end 322 b may beconnected to another portion of the body 321. The intermediate portion322 c of the impeding member 322 may be oriented toward the center (i.e.central axis) of the filter 320.

The impeding member 322 may be formed by cutting an aperture 324 intothe body 321 along the thickness of the body 321. The impeding member322 may be bent at the junction where the aperture 324 meets the body321 to extend the impeding member 322 in towards the center (i.e.central axis) of the filter 320. The impeding members 322, in thepresent embodiment, may be integrally formed with the body 321. In otherembodiments, the impeding member 322 may be attached to the body 321near the first end 322 a by welding, soldering, adhering, otherattaching methods, or combinations thereof.

Additional impeding members 326 may be integrally formed with and/or beconnected to the body 321 and/or the impeding member 322 to extendwithin and/or without the aperture 324. Additional impeding members 326may be attached to the body 321 and/or the impeding member 322 bywelding, soldering, adhering, other attaching methods, or combinationsthereof. The additional impeding members can be arranged to to helpcapture, inhibit, and/or lyse particulates in a body lumen.

FIG. 17 illustrates an exemplary subject 550 for an implantable lumenfilter 500. The implantable lumen filter 500 may be functionally similarto the implantable lumen filters 100, 170, 180, 190, 200, 250, 270, 280,290, 300, 310, 320 previously described above and shown in FIGS. 1-2 and5-16 and the implantable lumen filters 330, 350, 370, 390, 420, 440described below and shown in FIGS. 18-22 and 24-25 in most respects,wherein certain features will not be described in relation to thisconfiguration wherein those components may function in the manner asdescribed above and are hereby incorporated into the configurationdescribed below. The implantable lumen filter 500 may incorporate atleast one component of the implantable lumen filters 100, 170, 180, 190,200, 250, 270, 280, 290, 300, 310, 320, 330, 350, 370, 390, 420, 440described in connection with FIGS. 1-2, 5A-16, 18-22, and 24-25,respectively.

Although many of the embodiments herein may describe an implantablelumen filter 500, other filters may be deployed and/or retrieved usingat least one embodiment of a filter retrieval system described herein.The filter 500 may be implanted in a body lumen of the subject 550. Thefilter 500 may be inserted and/or retrieved through an access site 554a, 554 b, 554 c. In the present embodiment, the access site may includea femoral artery access site 554 a, a jugular vein access site 554 b, aradial vein access site 554 c, femoral vein, brachial vein, brachialartery, other access sites, or combinations thereof. For instance, thefilter 500 may be inserted through the femoral artery access site 554 aand retrieved through the jugular or radial vein access site 554 b, 554c. In another example, the filter 500 may be inserted through thejugular vein access site 554 b and retrieved through the femoral arteryor radial vein access site 554 a, 554 c. In a further example, thefilter 500 may be inserted through the radial vein access site 554 c andretrieved through the femoral artery or jugular vein access site 554 a,554 b.

The filter 500 may be inserted and retrieved through the radial veinaccess site 554 c. Additionally, the filter 500 may be inserted andretrieved through the jugular vein access site 554 b. Further, thefilter 500 may be inserted and retrieved through the femoral arteryaccess site 554 a.

The filter 500 may be deployed near a deployment site 556. In thepresent embodiment, the deployment site 556 may include a locationwithin the inferior vena cava. In other embodiments, other deploymentsites may be used, such as the superior vena cava. For example, thedeployment site 556 may include all larger veins.

Some implantable lumen filters typically use jugular, antecubital, orother access to sites for retrieval because they are typically notconfigured to be retrieved through the femoral access. Retrieval throughthe same access site through which the filter was deployed may bedesired. At least one embodiment of a filter retrieval system mayprovide for retrieval through the same access site through which thefilter was deployed.

FIGS. 18 and 19 illustrate a mechanism for retrieving a filter from abody lumen. As shown in the partial cutaway view of FIG. 18, a filter330 may include a retrieval portion 339. The filter 330 may incorporateany of the features and/or components of any of the filters describedherein. The retrieval portion 339 may include an eyelet 332. The eyelet332 may include a round end 334 with an aperture 336 through it. Theeyelet 332 may be positioned near at least one end of the filter 330.

A retrieving mechanism 340 may include a tube 342 configured to receivethe filter 330. The retrieving mechanism 340 may be guided through thebody lumen to a deployment site where the filter 330 may be located. Theretrieving mechanism 340 may include a wire 344 that may include aretrieval member 346 configured to engage the retrieval portion 339. Theretrieval member 346 may be hooked or otherwise shaped and is shown inhook shape in FIG. 18. The wire 344 may be directed to the filter 330 toengage the retrieval member 346 with the retrieval portion 339. Theretrieval member 346, in the present embodiment, may engage the aperture334 of the eyelet 332. The filter 330 may be directed toward the tube342 to receive at least a portion of the filter 330 and/or remove thefilter 330 from the body lumen.

In the partial cutaway view of FIG. 19, a filter 350 may include aretrieval portion 359. The filter 350 may incorporate any of thefeatures and/or components of any of the filters described herein. Theretrieval portion 359 may include a retrieval element 352 that may behooked or otherwise shaped and is shown in hook shape in FIG. 19. Theretrieval element 352 may be positioned near at least one end of thefilter 350.

A retrieving mechanism 360 may include a tube 362 configured to receivethe filter 350. The retrieving mechanism 360 may be guided through thebody lumen to a deployment site where the filter 350 may be located. Theretrieving mechanism 360 may include a wire 364 that may include aretrieval member 366 configured to engage the retrieval portion 359. Thewire 364 may include a retrieval member 366 configured to engage theretrieval portion 359. The retrieval member 366 may be shaped like asnare or may be otherwise shaped. The wire 364 can be directed to thespiral filter 350 to engage the retrieval element 352 with the retrievalmember 366. The filter 350 may be directed toward the tube 362 toreceive at least a portion of the filter 350 and/or remove the filter to350 from the body lumen. The retrieval member 366 may be used to engagea filter 350 by encircling the retrieval member 366 around a loop orother portion of the filter 350.

FIG. 20 is a partial cutaway view of an end of an embodiment of animplantable lumen filter 370. The filter 370 may incorporate any of thefeatures and/or components of any of the filters described herein.

The filter 370 may include a body 372 that coils (i.e. winds) in aspiral, helical, or other configuration Impeding members 374, 375, 376,377 may be positioned around a loop of the body 372. The impedingmembers 374, 375, 376, 377, in the present embodiment, may be positionednear one end of the filter 370. The members 374, 375, 376, 377 may bespaced around the body 372 at various orientations and are shown with aspacing of about 90 degrees and radiating toward the center (i.e.central axis) of the filter 370 in a generally circular fashion. Themembers 374, 375, 376, 377 may extend outward (i.e. away from thecentral axis) from the end of the filter 370 and may be configured toimpinge upon the bodily fluid flow through the body lumen.

A bushing 380 may be attached to at least one end of the members 374,375, 376, 377 on a side opposite the body 372. The bushing 380 mayinclude a head 382 that may be conical, may taper to a smaller diameter,or may taper to a point at one end (i.e. a spherical, oblong, pointed,or otherwise shaped head). The bushing 380 may include a hollow core 384that may extend from one end toward the other end and is shown extendingthrough the length of the bushing 380. The bushing 380 may be used tofacilitate retrieval of the filter 370 by receiving at least a portionof a retrieving mechanism (such as the retrieving mechanism 400described in conjunction with FIG. 22) into the hollow core 384.

FIG. 21 is a partial cutaway view of an end of another embodiment of afilter 390. The filter 390 may incorporate any of the features and/orcomponents of any of the filters described herein.

The filter 390 may include a body 392 that coils (i.e. winds) in aspiral, helical, or other configuration Impeding members 394, 395, 396,397 may be positioned around a loop of the body 392 near one end of thefilter 390. The members 394, 395, 396, 397 may be spaced around the body392 at various orientations and are shown with a spacing of about 90degrees and radiating toward the center (i.e. central axis) of thefilter 390 in a generally circular fashion. The members 394, 395, 396,397 may extend outward (i.e. to away from the central axis) from the endof the filter 390 and may be configured to impinge upon the bodily fluidflow through the body lumen.

A bushing 398 may be attached to at least one end of the members 394,395, 396, 397 on a side opposite the body 392. The bushing 398 can havea tube configuration with a plate 399 from one end of the bushing 398 tothe other. The bushing 398 may be used to facilitate retrieval of thefilter 390 by receiving at least a portion of a retrieving mechanism(such as the retrieving mechanism 400 described in conjunction with FIG.22) into lumen of the bushing 398. The plate 399 may limit the motion ofa retrieving mechanism in at least one direction.

FIG. 22 is a detailed view of an embodiment of a retrieving mechanism400. The retrieving mechanism 400 may include a tube 402 and a member404 extending through the tube 402. Rear facing pushing members 408 maybe positioned at or near the end of the member 404 and may be orientedto generally extend toward the tube 402. The rear facing pushing members408 may be flexible to move toward the member 404 while sliding into ahollow core, lumen, or other portion of a bushing (such as bushing 380of the filter 370 shown in FIG. 20) or other component of a filter.After the rear facing pushing members 408 extend through the bushing,the rear facing pushing members 408 may expand. For instance, the rearfacing pushing members 408 may extend past the outer diameter of thebushing. The rear facing pushing members 408 may be used to disengageand/or remove a filter from a body lumen.

Forward facing pushing members 410 can be attached to the member 404 ator near the tube 402. The forward facing pushing members 410 may be usedto direct a filter forward to adjust the filter within a body lumen orto remove the filter from the body lumen. The forward facing pushingmembers 410 may be used to capture a filter in conjunction with the rearfacing pushing members 408 to limit a portion of the filter from movingalong the member 404.

FIG. 23 illustrates a further embodiment of an implantable lumen filter420. The filter 420 may include a body 421 that coils (i.e. winds) in aspiral, helical, or other configuration. As shown in FIG. 23, the body421 coils in a spiral configuration. The filter 420 may incorporate anyof the features and/or components of any of the filters describedherein.

The body 421 and/or loops may have various shapes and/or sizes and isshown in an hourglass shape with varying loop sizes. As shown in FIG.23, loops 426 on ends 428, to 430 of the filter 420 may have a largerdiameter than loops 432 in an immediate portion 434 generally forming anhourglass configuration as indicated by the dotted lines. The hourglassconfiguration may facilitate the self-aligning of the filter 420 withinthe body lumen. The loops of the body 421 of the filter 420 may varybetween the ends 428, 430 and/or the intermediate portion 434.

The filter 420 may include retrieval portions 436, 438 that may bepositioned near the ends 428, 430 of the body 421. The retrievalportions 436, 438, as discussed above, may facilitate retrieval of thefilter 420 from the body lumen.

FIG. 24 illustrates a still further embodiment of an implantable lumenfilter 440. The filter 440 may include a body 441 that coils (i.e.winds) in a spiral, helical, or other configuration. As shown in FIG.24, the body 441 coils in a spiral configuration with varying loopsizes. The filter 440 may incorporate any of the features and/orcomponents of any of the filters described herein.

The body 441 and/or loops may have various shapes and/or sizes and isshown in a generally conic shape with varying loop sizes. Loops 446 onone end 448 of the filter 440 may have a larger diameter than loops 450on the opposing end 452. The conic configuration may facilitate aligningof the filter 440 since the larger loops may contact the body lumenwhile the smaller loops may remain suspended within the body lumen.

The filter 440 may include retrieval portions 454, 456 that may bepositioned near the ends 448, 452 of the body 441. The retrievalportions 454, 456, as discussed above, may facilitate retrieval of thefilter 440 from the body lumen.

FIGS. 25A-25G illustrate various steps in the deployment of animplantable lumen filter 800. The implantable lumen filter 800 may befunctionally similar to the implantable lumen filters 100, 170, 180,190, 200, 250, 270, 280, 290, 300, 310, 320 previously described aboveand shown in FIGS. 1-2, 5-16, 18-21, and 23-24 in most respects, whereincertain features will not be described in relation to this configurationwherein those components may function in the manner as described aboveand are hereby incorporated into the configuration described below. Theimplantable lumen filter 800 may incorporate at least one component ofthe implantable lumen filters 100, 170, 180, 190, 200, 250, 270, 280,290, 300, 310, 320 described in connection with FIGS. 1-2, 5-16, 18-21,and 23-24, respectively.

FIG. 25A illustrates a deployment site 856 within a body lumen 852 witha guidewire 861 partially inserted therethrough. The guidewire 861 maybe inserted through an access site (shown as 554 a, 554 b, 554 c in FIG.17) toward the deployment site to 856. The guidewire 861 may be used tolocate the deployment site 856. In other configurations, other methodsmay be used in addition to or instead of a guidewire 861. For example,an imaging device, such as a fluoroscope, x-ray, and/or other imagingdevice may be used to locate the deployment site 856.

As shown in FIG. 25B, a delivery apparatus 860 may use the guidewire 861to guide a distal end 860 b of the delivery apparatus 860 toward thedeployment site 856. An implantable lumen filter 800 may be disposedwithin the delivery apparatus 860. The implantable lumen filter 800, inthe illustrated configuration, may be disposed within the deliveryapparatus 860 while in a compressed state. While in the compressedstate, the implantable lumen filter 800 may be longitudinally elongatedwith respect to a deployed state.

The guidewire 861 may be removed after the distal end 860 b of thedelivery apparatus 860 is located near the deployment site 856.Alternatively, the guidewire 861 may remain.

A deployment member 862 may be inserted through the delivery apparatus860, as shown in FIG. 25C. The deployment member 862 may be used todeploy the implantable lumen filter 800. The implantable lumen filter800 shown in FIG. 25C is similar to the implantable lumen filter 100shown in FIGS. 1-2. In the configuration shown in FIG. 25D, thedeployment member 862 may urge the implantable lumen filter 800 towardthe distal end 860 b of the delivery apparatus 860 while the deliveryapparatus 860 may remain generally stationary.

The deployment member 862 may urge the implantable lumen filter 800 byabutting the proximal end 802 a of the filter 800. The deployment member862 may include a receiving area (not shown), such as a convex portionconfigured and dimensioned to receive the proximal end 802 a, tofacilitate urging the implantable lumen filter 800 out of the deliveryapparatus 860. As the implantable lumen filter 800 begins to exit thedelivery apparatus 860, the filter 800 may begin to transition from thecompressed state shown in FIG. 25C toward a deployed state.

A deployment member 862′ may be inserted through the delivery apparatus860′, as shown in FIG. 25C. The deployment member 862′ may be used todeploy the implantable lumen filter 800′. The implantable lumen filter800′ shown in FIG. 25C′ is similar to the implantable lumen filter 420shown in FIG. 23. In the configuration shown in FIG. 25D′, thedeployment member 862′ may urge the implantable lumen filter 800′ towardthe distal end 860 b′ of the delivery apparatus 860′ while the deliveryapparatus to 860′ may remain generally stationary.

The deployment member 862′ may urge the implantable lumen filter 800′ byabutting the proximal end 802 a′ of the filter 800′. The deploymentmember 862′ may include a receiving area (not shown), such as a convexportion configured and dimensioned to receive the proximal end 802 a′,to facilitate urging the implantable lumen filter 800 out of thedelivery apparatus 860′. As the implantable lumen filter 800′ begins toexit the delivery apparatus 860′, the filter 800′ may begin totransition from the compressed state shown in FIG. 25C′ toward adeployed state.

In the configuration shown in FIG. 25D″, the delivery apparatus 860′ maybe retracted while the deployment member 862′ may remain generallystationary. In other configurations, the delivery apparatus 860′ and/orthe deployment member 862′ may cooperate to facilitate deployment of theimplantable lumen filter 800′. For instance, the delivery apparatus 860′may be retracted while the deployment member 862′ may urge theimplantable lumen filter 800′ toward the distal end 860 b′ of thedelivery apparatus 860′. As the implantable lumen filter 800′ begins toexit the delivery apparatus 860′, the filter 800′ may begin totransition from the compressed state shown in FIG. 25C′ toward adeployed state.

FIG. 25E illustrates a deployed implantable lumen filter 800 within thebody lumen 852. In the deployed configuration, the implantable filter800 may engage an inside surface 853 of the body lumen 852. In thedeployed configuration, the implantable lumen filter 800 may belongitudinally reduced with respect to a collapsed configuration.

The implantable lumen filter 800″ shown in FIGS. 25F-25G may include aretrieval portion 830″ near the distal end 802 b″ of the implantablelumen filter 800″. The retrieval portion 830″ may be operativelyconnected to the distal end 802 b″ of the implantable lumen filter 800″.

The implantable lumen filter 800″ may be engaged by a retrieval member864. The retrieval member 864 may include a retrieving mechanism 866,such as a hook, snare, other retaining mechanism, or combinationsthereof, configured to engage the retrieval portion 830″. For instance,the retrieval member 864 may be similar to the retrieval members 346,366 described in connection with FIGS. 18-19. In other embodiments, theretrieval member 860 may be similar to the retrieval member 400described in connection with FIG. 22.

Upon engaging the retrieval portion 830″, the retrieval member 864 mayurge the implantable lumen filter 800″ into the retrieval apparatus 863.For example, urging the to implantable lumen filter 800″ toward theretrieval apparatus 863 may transition the filter 800″ toward thecompressed state.

In the illustrated configuration, the retrieval apparatus 863 and theretrieval member 864 may both move in generally opposite directions tourge the implantable lumen filter 800″ into the retrieval apparatus 863into a compressed state, such that the implantable lumen filter 800″ maybe longitudinally elongated with respect to a deployed state, as shownin FIG. 25G.

The implantable lumen filter 800′″ shown in FIGS. 25F′-25G′ is shownwith a retrieval portion 830′″ near the proximal end 802 a′″ of theimplantable lumen filter 800′″. The retrieval portion 830′″ may besimilar to the retrieval member 400 described in connection with FIG.22. In other embodiments, the retrieval portion 830′″ may be similar tothe retrieval portions 339, 359 described in connection with FIGS.18-19.

The implantable lumen filters 800′″ may be engaged by a retrieval member864. The retrieval member 864 may include a retrieving mechanism 866,such as a hook and/or other retaining mechanism, configured to engagethe retrieval portion 830″.

Upon engaging the retrieval portion 830′″, the retrieval member 864 maylimit motion away from the retrieval member 864. In the illustratedconfiguration, the retrieval member 864 may remain generally stationarywhile the retrieval apparatus 863 is advanced to urge the implantablelumen filter 800′″ into the retrieval apparatus 863.

In the present configuration, the retrieval member 864 remains generallystationary while the retrieval apparatus 863 moves to urge theimplantable lumen filter 800′″ into the retrieval apparatus 863 into acompressed state, such that the implantable lumen filter 800′″ may belongitudinally elongated with respect to a deployed state, as shown inFIG. 25G′. In other configurations, both the retrieval apparatus 863 andthe retrieval member 864 may move in generally opposite directions.

After the implantable lumen filters 800, 800′, 800″, 800′″ are withinthe retrieval apparatus 863, the retrieval apparatus 863 and implantablelumen filters 800, 800′, 800″, 800′″ may be withdrawn through an accesssite (shown as 554 a, 554 b, 554 c in FIG. 17).

In other embodiments, a filter may be expanded with a balloon to fitagainst a body lumen. Once in place, the catheter delivery system can beretracted and the radial members can spring into position after theballoon is deflated. The body and the radial members can have adifferent spring property by annealing the material in certain locationsdifferently to encode the springing properties into the components ofthe filter by applying different transformation temperatures to thematerial.

The invention is susceptible to various modifications and alternativemeans, and specific examples thereof have been shown by way of examplein the drawings and are herein described in detail. It should beunderstood, however, that the invention is not to be limited to theparticular devices or methods disclosed, but to the contrary, theinvention is to cover all modifications, equivalents, and alternativesfalling within the spirit and scope of the claims.

What is claimed is:
 1. An implantable lumen filter comprising: a bodyformed from an elongate member having a cylindrical, spiralconfiguration having loops encircling an axis extending along a lengthof the body, the body being sized to be implanted into a body lumen, thebody being configured to transition from a compressed cylindrical stateto a deployed cylindrical state; and a first plurality of memberspositioned around at least one loop of the body at a first positionalong the axis, the first plurality of members being oriented towardsthe axis, the first plurality of members being arranged to lyseparticulates of a selected size; a second plurality of memberspositioned around at least one loop of the body at a second positionalong the axis, and radiating towards the axis of the filter, the secondplurality of members being oriented to capture or inhibit theparticulates of another selected size from passing through the body, thesecond plurality of members being dimensioned to allow blood componentssmaller than the selected size and the another selected size to passthrough the body; wherein the second plurality of members is offset adistance from the first plurality of members along the length of thebody; and wherein the orientation of the first plurality of memberstoward the axis is different than the orientation of the secondplurality of members toward the axis.
 2. The implantable lumen filter ofclaim 1, wherein the body, the first plurality of members, and thesecond plurality of members are formed from a unitary wire member. 3.The implantable lumen filter of claim 2, wherein the first plurality ofmembers and the second plurality of members are formed by bendingportions of the unitary wire member toward the axis.
 4. The implantablelumen filter of claim 1, further comprising an engaging portionconfigured to engage an inner surface of a body lumen, the engagingportion including at least one of at least one tissue piercing portionconfigured to pierce at least a portion of an inner surface of the bodylumen and at least one tissue engaging portion configured to engage butnot pierce at least a portion of the inner surface of the body lumen. 5.The implantable lumen filter of claim 4, wherein the engaging portionsare connected to a side of the body to which the first and/or the secondplurality of members is connected, the engaging portions being bent toextend out from the body in a direction opposite to the first and/orsecond plurality of members.
 6. The implantable lumen filter of claim 1,wherein the body includes ends and an intermediate portion, the loops ofthe body being larger at an end than at the intermediate portion and/orthe loops of the body being larger at both ends than at the intermediateportion.
 7. The implantable lumen filter of claim 1, wherein the bodyincludes opposing ends, the loops of the body being larger at one endthan the opposing end.
 8. The implantable lumen filter of claim 1,further comprising a retrieval portion configured to facilitateretrieval of the implantable lumen filter from the body lumen.
 9. Theimplantable lumen filter of claim 1, wherein at least one of the firstor second plurality of members is oriented toward the axis of the filterat a steep incline to direct particulates away from the axis and towardsthe body.
 10. The implantable lumen filter of claim 1, wherein thesecond plurality of members includes more members than the firstplurality of members.
 11. The implantable lumen filter of claim 1,further comprising a filter material attached to and spanning across thefirst plurality of members.
 12. The implantable lumen filter of claim 1,further comprising ridges formed on the members of at least one of thefirst or second plurality of members, wherein the ridges are configuredto assist in capturing, inhibiting, and/or lysing particulates.
 13. Theimplantable lumen filter of claim 1, further comprising at least a thirdplurality of members.
 14. A method of making a spiral filter for a bodylumen, the method comprising: forming a body from an elongate memberhaving a cylindrical, spiral configuration having loops encircling anaxis extending along the length of the body, the body being sized to beimplanted into a body lumen to transition from a compressed cylindricalstate to a deployed cylindrical state; and forming a first plurality ofmembers positioned around at least one loop of the body at a firstposition on the axis, the first plurality of members being formed bybending portions of the elongate member of the body toward the axis, thefirst plurality of members being arranged to lyse particulates of aselected size; and forming a second plurality of members positionedaround at least one loop of the body at a second position on the axisand radiating towards the axis of the filter, the second plurality ofmembers being formed by bending portions of the elongate member of thebody toward the axis, the second plurality of members being orientatedto inhibit particulates of another selected size from passing throughthe body, the second plurality of members being dimensioned to allowblood components smaller than the selected size and the another selectedsize to pass through the body; wherein the second plurality of membersis offset a distance from the first plurality of members along thelength of the body; and wherein the orientation of the first pluralityof members toward the axis is different than the orientation of thesecond plurality of members toward the axis.
 15. The method of claim 14,wherein the elongate member is at least one of a wire, a wire flattenedbefore being formed into a spiral configuration, and a ribbon.
 16. Themethod of claim 14, further comprising forming engaging portions on thebody and bending the engaging portions out from the body in a directionopposite to the elongate member, the engaging portions being formed onat least one of the same side of the body as the first plurality ofmembers or a side of the body opposing the side where the firstplurality of members are located.
 17. The method of claim 14, where thedistance by which the first and second plurality of members are offsetis about ⅔ of the total length of the body.
 18. The method of claim 14,wherein the body, the first plurality of members, and the secondplurality of members are formed having a different spring property byannealing the body, the first plurality of members, or the secondplurality of members in certain locations differently.
 19. A method ofdeploying a filter in a body lumen, the method comprising:longitudinally elongating an implantable lumen filter such that theimplantable lumen filter has a reduced dimension, the implantable lumenfilter comprising: a body formed from an elongate member having acylindrical, spiral configuration having loops encircling an axisextending along a length of the body, the body being sized to beimplanted into a body lumen, the body being configured to transitionfrom a compressed cylindrical state to a deployed cylindrical state; anda first plurality of members positioned around at least one loop of thebody at a first position along the axis, the first plurality of membersbeing oriented towards the axis, the first plurality of members beingarranged to lyse particulates of a selected size; a second plurality ofmembers positioned around at least one loop of the body at a secondposition along the axis, and radiating towards the axis of the filter,the second plurality of members being oriented to capture or inhibit theparticulates of another selected size from passing through the body, thesecond plurality of members being dimensioned to allow blood componentssmaller than the selected size and the another selected size to passthrough the body; wherein the second plurality of members is offset adistance from the first plurality of members along the length of thebody; wherein the orientation of the plurality of first members towardthe axis is different than the orientation of the second plurality ofmembers toward the axis; and loading the implantable lumen filter in adelivery system.
 20. The method of claim 19, wherein the filter isdeployed in the body lumen by at least one of pulling the deliverysystem away from the filter or pushing the filter out from the deliverysystem to release the filter to deploy the filter from at least one ofthe following one end of the delivery system or a middle section of thedelivery system.
 21. The method of claim 19, wherein, as the filter isdeployed, at least one of the following occurs: the filter expands outagainst the body lumen and the first and second plurality of membersspring into place or the filter is expanded with a balloon to fit thefilter against the lumen and the first and second plurality of membersspring into position after the balloon is deflated.
 22. The method ofclaim 19, further comprising retrieving the filter from the body lumen,comprising the steps of: locating the filter deployed in the body lumenat the deployment site; delivering a retrieving mechanism to thedeployment site of the filter in the body lumen, capturing the filterwith the retrieving mechanism; and retrieving the filter from the bodylumen by retracting the retrieving mechanism.
 23. The method of claim22, wherein the retrieving mechanism includes a tube and a wire, thewire extending through the tube, and a snare attached to the end of thewire.